DEVICE: COBRA (04055207013748)
Device Identifier (DI) Information
COBRA
7326071
In Commercial Distribution
7326071
Richard Wolf GmbH
7326071
In Commercial Distribution
7326071
Richard Wolf GmbH
FIBER-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.3Fr, working channel 1: 3.3Fr, slanted distal tip Ø 6 Fr, TL 1010mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, glass fiber light cable, fiber image carrier, manual focus
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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37111 | Flexible fibreoptic ureterorenoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used for the removal or crushing of stones, pyelitis, and renal failure. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FAJ | Cystoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 3.3 Millimeter |
Length: 680 Millimeter |
Device Record Status
c57935cf-19f0-4127-9615-c443f083c520
April 26, 2021
3
September 23, 2016
April 26, 2021
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com